FDA Panel Rejects OTC allergy drug Singulair

FDA Panel Rejects OTC allergy drug Singulair

The U.S. FDA panel has rejected Merck’s application for approval of its prescription drug Singulair as over the counter medication. The FDA panel voted 11-4 against the asthma and allergies drug Singulair.

Singulair has been a blockbuster drug for Merck for years. However, the sales have dropped as the patent expired in 2012. The generic versions are available at lower price and Merck aimed at OTC status for the drug to revive sales.

FDA panel noted that Singulair has side effects in some individuals including headache, behavioral changes, anxiety, depression, hallucinations and bed wetting.
The drug would not be good as an over-the-counter medication as medical experts should consider the side effects in patients before prescribing it. Currently, a high percentage for children is prescribed Singulair.

Dr. Andrew Ting, an assistant professor of pediatrics and critical care at The Mount Sinai Hospital in New York City, said, “The risk of asthmatics using Singulair as a rescue medication or in place of an oral corticosteroid such as prednisone could lead to a significant delay in appropriate treatment for exacerbations.”

Dr. Harlan Weinberg from Northern Westchester Hospital added that medication interactions are a major concern. The OTC status for Singulair could pose risk to children, pregnant women and other patients self-medicating asthma.

Nearly 40 percent of allergy patients switch their medication. An over the counter status could lead to many people trying the medication without considering possible side effects.

Merck submitted a study of 15-17 year old subjects. Most of them considered Singulair was right for them even when the drug has been clearly labeled ‘only for adults’.


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